Exosome as the Prognostic and Predictive Biomarker in EBC Patients

Not Applicable

Active, not recruiting

• Conditions: HER2-positive Breast Cancer; Triple Negative Breast Cancer
• Interventions: Procedure: exosome and ctDNA evaluation

• Registration Number: NCT05955521
• Lead Sponsor: Samsung Medical Center

Brief Summary

This study is the experimental study for serial ctDNA and exosome evaluation in EBC patients

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Status Verified: 2023-07
• Primary Completion: 2023-07-01
• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-21
• Last Update Posted: 2023-07-21
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Early breast cancer
• Planned neoadjuvant chemotherapy
• Triple negative breast cancer or HER2-positive breast cancer

Exclusion Criteria

• Stage IV breast cancer
• Hormone receptor positive breast cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CtDNA/Exosome evaluation	exosome and ctDNA evaluation	-

Primary Outcome Measures

Name	Time	Method
Prognostic biomarker for EBC	60 months	Positive predictive value of ctDNA/Exosome for BC recurrence

Trial Locations

Locations (1)

Ji-Yeon Kim; 🇰🇷 Seoul, Korea, Republic of